A PhaseI Study of HL-085 Plus Vemurafenib in Solid Tumor With BRAF V600 Mutation

Solid Tumor Clinical Trial

Official title:

A Phase I, Single Arm, Dose Escalation Study to Evaluate Safety, Pharmacokinetics and Preliminary Efficacy of HL-085 Plus Vemurafenib in Patients With BRAF V600 Mutant Advanced Solid Tumor

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03781219
• Other study ID #: HL-085-102
• Status: Recruiting
• Phase: Phase 1
• Start date: July 1, 2018
• Est. completion date: December 1, 2023

Study information

• Verified date: May 2023
• Source: Shanghai Kechow Pharma, Inc.
• Contact: Jin Ma, Bachelor
• Phone: 86 13810268600
• Email: maj[@]kechowpharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a phase I, open-label, dose escalation study to evaluate tolerability, safety, pharmacokinetics and efficacy in patients with BRAF V600 mutant advanced solid tumor by HL-085 plus Vemurafenib treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. BRAF V600 mutation in solid tumor.

2. One measurable lesion as defined by RECIST 1.1 criteria for solid tumors.

3. Chemotherapy, immunotherapy or radiotherapy = 4 weeks prior to starting the study treatment.

4. Surgery (except for tumor biopsy) or severe trauma = 14 days prior to starting the study treatment.

5. ECOG performance status of 0-1.

6. Life expectancy = 3 months.

7. Ability to take the medicine orally.

8. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

1. Hypersensitivity to study drug ingredients or their analogues.

2. Prior therapy with MEK-inhibitor.

3. Receiving any other anti-cancer therapy at the same time .

4. Active central nervous system (CNS) lesion.

5. Bleeding symptoms at Grade 3 within 4 weeks prior to starting study treatment.

6. ECG QTcB=480msec in screening, or history of congenital long QT syndrome;

7. Uncontrolled concomitant diseases or infectious diseases.

8. Retinal diseases (Retinal Vein Occlusion (RVO) or Retinal pigment epithelial detachment (RPED) , et al.).

9. History of HIV,HCV,HBV infection.

10. Interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis will be excluded.

11. Serum HCG test is positive.

12. Other conditions that increase the risk of study and influence the result.

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

Intervention

Drug:
• HL-085
HL-085 ( Capsule) is one MEK inhibitor.
• Vemurafenib
Vemurafenib ( Tablet) is BRAF inhibitor,

Locations

Country	Name	City	State
China	Beijing Oncology Hospital	Beijing	Beijing
China	Cancer Hospital Chinese Academy of Medical Science	Beijing	Beijing
China	First Affiliated Hospital, Medicine School of Zhejiang University	Hangzhou	Zhejiang
China	Henan Province Oncology Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Kechow Pharma, Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Adverse Events	Number of Treatment-Related Adverse Events as Assessed by CTCAE v4.03 will be counted.	up to 12 mouths